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New biologic aims to tackle stubborn high triglycerides

NCT ID NCT07680829

Disease control Sponsor: Zhejiang Doer Biologics Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 02, 2026 · Last updated Jul 07, 2026 · Updated 2 times

Summary

This phase 3 trial tests an investigational injectable drug called DR10624 in adults with severe hypertriglyceridemia (very high blood fats) that remains high despite standard treatment. Participants continue their usual omega-3 therapy and receive weekly injections of DR10624 or a placebo. The study measures how much triglycerides drop over 26 weeks and checks safety and other lipid levels.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
DR10624 (injectable biologic) plus icosapent ethyl (oral omega-3)
What this could lead to
If successful, this could offer a new add-on treatment option for people with severe high triglycerides that are not controlled by current therapy.
What could go wrong
This is a phase 3 trial, but the drug is still investigational. It may not prove effective or could have side effects. Results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 378 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Oct 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age ≥18 years, male or female; BMI 19.0-45.0 kg/m², body weight ≥50 kg at screening. 2. Fasting triglyceride (TG) range 5.65-22.60 mmol/L: single screening lab result meets range, plus average of two separate fasting TG tests (interval \>1 week) within same range prior to randomization. 3. Stable lipid-lowering medications per local guidelines if on statin, cholesterol absorption inhibitor or PCSK9 inhibitor (minimum stable dose duration as required by drug class). 4. Females of childbearing potential agree effective contraception from ICF signing to 2 months post last dose; male participants agree contraception and no sperm donation for 3 months post last dose. 5. Able to understand study procedures, maintain consistent lifestyle and follow all protocol-specified requirements, and provide written informed consent. Exclusion Criteria: 1. Confirmed hereditary lipid disorders (Fredrickson Type 1/3, Apo C-II deficiency). 2. Significant weight loss or planned weight reduction during study. 3. Severe chronic liver, renal or advanced cardiac disease. 4. Uncontrolled diabetes or hypertension with severe complications. 5. Pancreatitis history or symptomatic gallbladder disease. 6. Recent major cardiovascular, bone or thyroid disorders. 7. Severe psychiatric illness or substance abuse history. 8. Prior GLP-1/GCGR/FGF21 agonists or other investigational drugs within 3 months. 9. Abnormal screening lab parameters related to liver, pancreas, kidney or viral infection. 10. Pregnant, breastfeeding or hypersensitivity to study treatments. 11. Investigator's judgment of unsuitability for participation.

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Conditions

The condition(s) this trial relates to.

hypertriglyceridemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Severe hypertriglyceridemia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Peking University First Hospital

    Beijing, China

  • Peking University People's Hospital

    Beijing, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.